As the FDA is poised to authorize the new Pfizer and Merck pills to treat those with Covid-19 who haven’t been hospitalized, Bloomberg reports that the US will only have limited supplies of each pill initially.
US officials said Americans should have nearly 400,000 courses of Merck’s pill available upon its authorization and 65,000 courses of Pfizer’s pill. By the end of January, the government expects 3 million Merck courses — its entire order — and 250,000 Pfizer courses. Merck’s pill has been shown to be less effective in early trials than Pfizer’s, although Merck did not test its pill head-to-head against Pfizer.
Biden’s administration also apparently offered Pfizer the support of the US government if it runs into any production issues, including use of the Defense Production Act, but Pfizer ‘hasn’t needed any intervention,’ citing the pill’s ‘lengthy, intensive manufacturing process’ to Bloomberg.
Meanwhile, the UK on Wednesday bought an additional 2.5 million treatment courses (on top of 250,000 bought previously) of Pfizer’s pill, and 1.75 million courses of Merck’s pill.
Israel goes for a 4th dose of Pfizer’s vaccine for those over 60
Israel said Wednesday that it will administer a fourth dose of coronavirus vaccine to people over the age of 60 and medical personnel, becoming the first nation in the world to do so, according to Bloomberg.
Those eligible for the fourth dose can receive it provided at least four months have passed since the third dose, the country’s prime minister’s office said, according to CNN. In Israel, almost all vaccinated citizens have received the Pfizer/BioNTech vaccine.
AstraZeneca to make Omicron-specific vaccine
AstraZeneca and Oxford University have teamed up to make a vaccine specific to the Omicron variant, joining Pfizer-BioNTech and Moderna to do so.
The news comes following a study in The Lancet that protection offered by the AstraZeneca jab wanes three months after vaccination, while other evidence suggests that a two-dose shot course provides fewer antibodies against Omicron, and that a third mRNA shot can increase the number of antibodies. AstraZeneca’s shot is adenovirus-based.
‘Like with many previous variants of concern, and together with our partners AstraZeneca, we have taken preliminary steps in producing an updated vaccine in case it is needed,’ Oxford research group leader Sandy Douglas said to the Financial Times.
AstraZeneca’s shot has not been approved in the US, though it was used throughout the UK and Europe before access was restricted due to rare, but fatal blood clots being linked as a side effect.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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Another bad week for Biogen and its Tokyo-based partners at Eisai was extended on Wednesday with news that a panel review of their controversial Alzheimer’s drug aducanumab earned a pushback from the health ministry in Japan.
According to overnight news reports, their panel concluded that inconsistent Phase III data and lack of clinical significance in reducing amyloid plaque in patients made it difficult to determine if the therapy worked, but offered to review it again once the 2 partners lined up more data.
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Michael Yang, ViaCyte CEO
Over the last 20 years, ViaCyte — under one name or another — has pursued one of the most audacious goals in biotech: a cure for type 1 diabetes.
The company’s plan was to take lab-grown stem cells and turn them into the insulin-producing cells that are destroyed in T1D patients. The first attempt to implant these cells into patients in 2014 failed entirely. But the San Diego biotech regrouped and launched trials for a new candidate in 2017, raising $80 million in the process.
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Harvard University professor Charles Lieber leaves federal court, Tuesday, Dec. 14, 2021, in Boston (Michael Dwyer/AP Images)
In a stunning climax to an eye-catching saga, Harvard scientist Charles Lieber has been convicted of lying to the federal government about his ties to China’s Thousand Talents Program.
Following close to three hours of deliberation, a federal jury in Boston found 62-year-old Lieber — a pioneer in medical nanotechnology and the former chair of Harvard’s chemistry department — guilty of all six felony charges, including two counts of making false statements, two counts of filing false tax returns and two counts of failing to disclose a foreign (in this case Chinese) bank account.
Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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The FDA may soon sign off on two new pills from Merck and Pfizer to help treat Covid-19 before those infected end up in the hospital, according to a Bloomberg report.
An announcement from the agency may come as early as Wednesday, according to three Bloomberg sources, which would create more options for those who are unvaccinated and need quick and early treatment.
Most recently, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the Merck pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms. But Merck offered little explanation for why its potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, and mutagenesis concerns remain.
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